First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

Main Inclusion Criteria:

- Histologically or cytologically confirmed relapsed/refractory hematological malignancy
or advanced/metastatic solid cancer

- Measurable disease

- Have had all available therapeutic standards for their disease

- Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not
collected after completion of the most recent prior therapy

- ECOG performance status ≤ 1

- Life expectancy > 3 months as assessed by the investigator

- Acceptable clinical lab results

Main Exclusion Criteria:

- Systemic steroids at a daily dose of > 10 mg of prednisone or equivalent within 28
days before study treatment. Transient use of steroids for other medical condition may
be allowed

- Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous
therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss,
and stable endocrinopathies with substitutive hormone therapy

- Within 4 weeks of major surgery

- Documented history of active autoimmune disorder requiring systemic immunosuppressive
therapy within the last 12 months

- Prior solid organ transplant

- Primary or secondary immune deficiency

- Active and uncontrolled infection requiring intravenous antibiotic or antiviral
treatment

- Seropositive (except after vaccination or confirmed cure for hepatitis) for human
immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

- Clinically significant disease